kwok infection concerns and solutions in endoscopy...
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Infection Concerns and Solutions in the Endoscopy Suite43rd Annual Seminar for GI Nurses and Associates
Karl Kwok, MDCenter for Pancreatic CareKaiser Permanente, Los Angeles Medical CenterSeptember 21, 2019
Division of Gastroenterology, Department of Medicine
Disclosures
2 | © 2019 Kaiser Foundation Health Plan, Inc.September 13, 2019
• Boston Scientific – Clinical Education Training
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Agenda Slide
Introduction
Sources of risk in the GI lab
Multifactorial cause of endoscope infection
“Low-tech” and “High-tech” solutions
Summary and recommendations
Introduction
The problem is real, and is on the public’s mind
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NYTimes.com , accessed 8/6/19Arstechnica.com , accessed 8/25/19
BUT, endoscope infections are not new!
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1975, Pseudomonas, ineffective disinfectant
1980, Pseudomonas, ineffective disinfectant / no brushing
1984, Pseudomonas, ineffective disinfectant & A/W channel not washed
1985, Pseudomonas, ONLY tap water flush between cases!
1988, Pseudomonas, contaminated lens wash bottle / basin, no drying
1993, Pseudomonas / Klebsiella, defective AER
Elson 1975Low 1980
Cryan 1984Earnshaw 1985
Struelens 1993Image: giphy
Resistance to biocides (most to least)
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• ≥ sterilizationBacterial Spores (e.g. C. Difficile)
• ≥ high-level disinfectionMycobacterial (e.g. M. Tuberculosis)
• ≥ intermediate-level disinfectionNon-lipid or small viruses (e.g. Poliovirus)
• ≥ low-level disinfectionFungi (e.g. Candida)
• ≥ low-level disinfectionLipid or medium-sized viruses (e.g.
HIV)
• ≥ low-level disinfectionVegetative bacteria (e.g.
pseudomonas, CRE)
Adapted from Endoscopy Handbook 2nd Ed, p12
What is Enterobacteriaceae? (CRE)
§ Family of 70 commonly-found GUT flora § Opportunistic infections
– Asymptomatic CRE colonization can occur– Immunocompromised state increases risk of active infection
§ Bone Marrow Transplant§ Hematology-oncology wards
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Oren 2013Muscarella LF 2014
Carbapenem resistance (CRE)
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WikipediaMuscarella LF 2014
Furuya EY 2006
• Carbapenem – beta lactam ring (similar to penicillins)
• Resistance may occur through• Antibiotic resistance gene transfer
(right)• active drug removal• alteration of bacterial target, etc
The rise of CRE
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Adapted from McKenna M, 2013
1. ‘96, NC ICU – KPC resistance gene2. ‘03, spread thru NYC; ‘07, 21% KPC gene
3. ‘05, Israel, UK, Sweden, Italy, Columbia4. ‘08, Sweden discovers new gene, NDM
Sources of risk in the GI lab
Where is the possible source of infection risk?
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Image: maniladoctors.com.ph
The patient?
The scope?
The environment?
Answer: ALL OF THE ABOVE
1. Source of risk – patient (“people”)
Poor functional status /
incontinence
Long term care
residents (SNF)
Open
wounds
Indwelling catheters
(central lines / ET tubes)
Inappropriate antibiotic usage
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CRE colonization
Long term care pts (lines, incontinence, etc.)
§ T cell function decreases among the elderly
§ PLUS multi-hit hypothesis– Malnutrition, chronic illness,
Functional impairments§ reduced continence, cough
reflex– ~ 50% of LTC patients with
assistive needs (graph)– “Sicker patients, sooner”
§ Higher rates of antibiotic usage
010002000300040005000600070008000
Infusion therapy PICC lines TPN
Survey of 15k LTC facilities (’04)
facili ties offering service (n)
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Smith 2008
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Inappropriate antibiotic use / resistance
Overuse – farm Overuse – Doctor’s office Overuse – hospital
80% of US rx – farming
Feed, to soil, to processor, to you
80% of EU rx – URI
US MD – Patient Satisfaction Scores?
30-60% of ICU rxunnecessary, not
appropriate, suboptimal
Consumer Reports, 2015 European CDC, 2014 Luyt CE 2014
2. Source of risk – environment (“places”)
§ Sink Drain Design Can Directly Impact CRE dispersal
§ Slow drain (≥ 10 sec) & drain opening directly underneath faucet opening: significant dispersal of CRE up to 1m (p < 0.001)
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Aranega-Bou 2019
Forward viewing scopes ERCP / linear EUS scopes
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Holland 2002Verfaillie 2015
Holland 2000
Suction- Up to 3.7mm
diameter- BUT >90° at
valve
Air/water- 1.5mm
diameter
Elevator wire / sus pipe (coil pipe)- 0.185mm
diameter- “SEALED” optics
/ elevator wires: fault tolerance?
3. Source of risk – endoscope (“things”)
Multifactorial causes of endoscope infection
Multifactorial causes of endoscope infection
Complex instructions / complex design
Human factors
Biofilm
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CRE infection
Complex instructions: Reprocessing steps / use
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020406080
100120140160180
Vendor 1 Vendor 2 Vendor 3
Number of steps (not including AER)
§ 2013, WA: 3% persistent duodenoscope infection despite exceeding reprocessing guidelines§ 2015, CA: CRE transmission through duodenoscopes (culture negative)Wendorf 2015Kim 2016
Image: Unicode / Apple
Complex design: Very narrow margin of safety
110
1001000
10000100000
100000010000000
1000000001E+091E+10
After use After pre-cleaning
After HLD
Remaining bacteria (normal circumstances)Remaining bacteria (heavily soiled)
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Rutala 2008Kovaleva 2013
Isaacson WHO 2009
§ Assumes EVERY step properly performed!
§ Meticulous Pre-cleaning is essential
– Germicide contact time to kill§ 10 bacterial spores: 30
minutes§ 100,000 bacterial spores:
3 hours
Human factors: heuristic analysis
§ 75% feel pressure to work quickly
– Physicians rushing the staff washers è rush & skip steps
§ Top 3 violations in endoscope reprocessing
– Feedback– Visibility– Memory
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Ofstead 2010Hildebrand 2010
Human factors
§ Improper elevator position (open instead of 45° closed)– After only 1 round of reprocessing, viable bacteria remains under the elevator
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Alfa 2018Video: youtube
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Biofilm
§ Bacteria can be planktonic (free floating), but prefer to be assembled in biofilm
– Can occur in any surface, from water supply systems, to paper mills, to endoscopes
§ Confers survival advantage– 1000-fold resistance to chemicals / antibiotics
§ Changes in growth rate and gene transfer (e.g. antibiotic resistance genes) can occur
Kovaleva J 2013Donlan RM 2002
ERCP transmission of CRE: Swiss cheese model
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Data adapted from Kim 2016Image: (CC BY-SA 3.0). Modified from original by David Mack
“Low-tech” and “High-tech” solutions
Low tech: Screening for CRE?
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§ Rectal (peri-rectal) swab culture– 83.8% sensitivity, 89.2% specificity
(meta-analysis 28 studies)
§ Culture vs PCR?– Culture: ~96h turnaround, $22k / yr– PCR: ~24h turnaround, $224k / yr
Richter 2017
Low tech: Decontaminate the Gut?
§ CRE colonizes the gut§ Chemotherapy -> mucositis ->
recurrent bloodstream infection§ 152 consecutive patients,
randomized into 1, 2, or both drugs (see flowchart)
§ If eradicated, 17% mortality; if FAILED eradication, 49% mortality (p = 0.002)
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Oren 2013
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Low tech: “Do More”?
ATP < 200 RLU? FDA guidance – 4 options Post-Disinfection Tests
Proper technique (maybe)
Poor correlation between RLU and “cleanliness”
FDA 522: 7.5x more infx
RCT of 1/2/EtO: no difference in >10 CFU
GNR enzyme activity
PCR
CDC culture protocol?Sethi 2017Visrodia 2017
Accessdata.FDA.govSnyder 2017
Lichtenstein and Alfa 2019Gazdik 2016
Ofstead 2017 selectech.co.za
“If 1 is good, 2 must be better… right?”
§ Randomized control trial of single HLD, double HLD, or EtOgas sterilization
§ 516 washes§ Study terminated after 3 months
due to futility (no MDRO detected)
§ No difference among the 3 arms for culture positivity
Trial arm
N ≥ 1 MRDO
>0 CFUa
≥ 10 CFUb
sHLD 174 0 28 (16.1%)
4 (2.3%)
dHLD 169 0 27 (16%)
7 (4.1%)
HLD/ EtO
173 0 39 (22.5%)
9 (4.2%)
Total 516 0 94 (18.3%)
20 (3.9%)
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a p = 0.21b p = 0.36 by Fisher exact test
Snyder 2017
ポカヨケ (“Poka-yoke”)
§ System designed to be error proof
§ Pioneered by Industrial Engineer Shideo Shingo (Toyota)
§ GOOD: depress brake pedal before shifting from park
§ BAD: An example how NOT to design a system (image)
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Low tech: Is there utility of Borescope exam?
§ Control arm: preclean, manual brush, AER with 2.5% glutaraldehyde
§ Intervention arm: preclean, manual brush, ATP (with more brush as needed), AER with peracetic acid
§ Findings– ATP gastroscopes > colonoscopes (p =
0.001)– Biopsy port ATP > suction-biopsy
channel ATP (p = 0.005)– Intervention arm cleaner but
significance? (two variables changed)– Unknown: value of borescope?
(clinical relevance?)
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Ofstead 2016A, B: control arm t=0 and 2moC, D: intervention arm t=0 and 2mo
Low tech: Disposable buttons / caps
§ FDA recommendation 2016 allows either reprocessed valve or single-use valve / caps
§ Reusables HARD TO CLEAN
§ Infection can be transmitted!– M tuberculosis (contaminated
bronchoscopy valves)
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Kovaleva 2013Images: Parente 2009, Ackert-Burr 2015 (APIC)
Low tech: Timed Drying
§ 23 total scopes (FWD & Elev)§ 3 arms
– Manual (10 min, air gun)– Automated (5 min)– Automated (10 min)
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Barakat 2019
§ Results– Dryness: auto (10) > auto (5) > manual
(10, air gun) (p < 0.01 for group)– Lower ATP levels after 48h: auto (10) >
auto (5) > manual (p < 0.001)– Addresses human factor (inattentive
blindness / lack of concentration)
High tech: Single-use?Duodenoscope cap
§ Released December 2017§ Intent: makes cleaning easier§ But: more acute angles &
crevices?
ENTIRE DUODENOSCOPE
§ FDA 510k approval (K173085) for upper / lower endoscopes in September 2017
§ Duodenoscope market release anticipated 2020
§ Well-known GI consumables market vendor also testing
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Pentaxmedical.com Ambu.comClinicaltrials.gov (NCT03701958)
High tech: Plasma-activated argon gas§ Activity is through reactive
Oxygen & Nitrogen species– Works against MDRO, spores,
biofilm, fungi; bacteria cannot develop resistance
§ 120cm & 220 cm long tubes§ PAG exposure time to
completely eradicate biofilm at distal end (furthest away from plasma gas), for 24h biofilm –see table
§ No visible PTFE tube damage on SEM
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Bhatt 2019
Organism 120cm tube 220 cm tubeE coli 1 min 5 minP aeruginosa 2 min 9 minMRSA 1 min 9 min
§ Not yet commercially available§ But, per authors
– Materials cost $2000– Pathway for 510k (maybe)
Summary and Recommendations
5 Do’s and Don’ts to prevent endoscope infections
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DON’TS
Ignore the problem –“it’s never happened in our unit”
“Poka-Yoke”
Hang wet scopesForced air drying
Ignore QC for scope washers / equipment
Regular QC of scope washers / equipment
RUSH SCOPE WASHERS
Identify & respond to high-risk patients
Allow scopes to cakeTimely & thorough reprocessing
DO’S
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Thank you
— Sir William Osler
“Soap and water and common sense are the best disinfectants”